Effectiveness and Safety of Metformin, Teneligliptin, and Glimepiride Combination Therapy in Type 2 Diabetes: A Quasi Experimental Clinical Trial.

Abstract

Introduction: Type 2 Diabetes Mellitus (T2DM) accounts for more than 95% of all diabetes cases and is a leading cause of disability and death. This study aimed to evaluate the effectiveness and safety of a combination therapy involving metformin, teneligliptin, and glimepiride in patients diagnosed with T2DM.

Methods: The present quasi-experimental clinical trial involved 300 adult T2DM patients. They were divided into three groups: Group 1 (Metformin; n=100), Group 2 (Metformin + Teneligliptin; n=100), and Group 3 (Metformin + Teneligliptin +; n=100). Along with demographic data, we collected information on HbA1c, FBS, and PPBS levels, as well as fasting insulin, CPeptide, HOMA-IR, QUICKI-IR, and lipid, renal, and hepatic profiles at baseline and after 3, 6, and 12 months. Data analysis was performed using SPSS 21.0 software.

Results: A total of 300 patients participated in the study. At the end of 12 months, triple-drug therapy achieved significant glycemic control (HbA1c: 6.56±0.50%; P<0.0001) and reduced FBS (7.6±1.41 mg/dl; P<0.0001), PPBS (9.39±2.14 mg/dl; P<0.0001), and fasting insulin (11.26±2.5 IU; P<0.0001), C-peptide (2.01±2.29 ng/ml; P<0.0001), and insulin resistance by HOMA-IR (3.74±0.7; P<0.0001). Favorable lipid profiles (P<0.0001) were noted versus other groups. Despite renal and hepatic profile variations, values remained within the normal range.

Conclusion: The combination of teneligliptin with metformin and glimepiride in T2DM patients demonstrated significant improvements in glycaemic control, reduced insulin resistance, and positive effects on lipid, renal, and hepatic profiles. Importantly, the therapy did not result in serious adverse drug reactions, such as hypoglycemia. We need more RCTs to substantiate these findings.